Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01012908
First received: November 11, 2009
Last updated: October 26, 2010
Last verified: November 2009
  Purpose

The primary objective of this clinical trial is to demonstrate non-inferiority clinical development of pancreatic enzymes from Laboratory Bergamo (Norzyme ®) in relation to pancreatic enzymes from Solvay Pharmaceuticals (Creon ®), by comparing the average amount of lipids in the feces of 72 hours after 14 days of treatment with each drug.


Condition Intervention Phase
Pancreatic Insufficiency
Dietary Supplement: Norzyme - Bergamo
Dietary Supplement: Creon
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Amount of fat in the stools of 72 hours of medication use between the two treatments. [ Time Frame: First period: 12th, 13th and14th day. Second period (After crossover medication): 12th, 13th and14th day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of bowel movements per day [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ] [ Designated as safety issue: Yes ]
  • Consistency and characteristics of feces [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ] [ Designated as safety issue: Yes ]
  • Frequency and intensity of abdominal pain daily [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ] [ Designated as safety issue: Yes ]
  • Frequency of flatulence daily [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ] [ Designated as safety issue: Yes ]
  • Amount of drug used in treatment [ Time Frame: First period: days 1 - 14. Second period: days 1-14. (every day) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: March 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norzyme
Pancreatic Enzymes - Norzyme (Bergamo)
Dietary Supplement: Norzyme - Bergamo
2 - 8 tablets per day.
Active Comparator: Creon (Solvay)
Pancreatic Enzymes - Creon (Solvay)
Dietary Supplement: Creon
2 - 8 tablets pet day

Detailed Description:

As a secondary objective will be assessed the following parameters:

  • Incidence of abdominal pain;
  • Frequency of flatus;
  • Frequency of bowel movements during the treatment;
  • Consistency of stools during treatment;
  • Amount of medication used among the treatments. All these parameters will be measured based on reports of patients in a specific diary.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must agree with the purposes of the study and sign the Informed Consent in two ways;
  • Be aged over 18 years;
  • Display chronic exocrine pancreatic insufficiency due to chronic pancreatic, post surgical or other situation that leads to severe glandular disease;
  • Doing controlled clinical treatment of enzyme replacement with Creon ® 25,000 (or similar with the same concentration of lipase) during meals;
  • Agree to record daily food intake in phase 2 and repeat the diet in phase 3;
  • Present ability to meet the patient's diary;
  • Be clinically compensated with replacement therapy;
  • Must be admitted patients in both the sexes;
  • Must be accepted patients of any ethnicity.

Exclusion Criteria:

  • Cystic fibrosis;
  • Acute pancreatitis;
  • Participation in any experimental study or ingestion of any experimental drug in the 12 months preceding the study;
  • Diabetes decompensated;
  • Regular use of medications that interfere with the action of the drug test: the 4 weeks preceding the study or any medication that interferes with the drug test a week before the start of the study;
  • Any type of treatment for morbid obesity;
  • Abusive use of alcohol in the three months preceding the study;
  • Pregnancy and lactation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012908

Locations
Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01012908     History of Changes
Other Study ID Numbers: PANBER0609
Study First Received: November 11, 2009
Last Updated: October 26, 2010
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Exocrine Pancreatic Insufficiency
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 30, 2014